Transcatheter Arterialization of Deep Veins in No-Option CLTI Patients: 1-Year Outcomes from the PROMISE II Study

Introduction: Chronic limb-threatening ischemia (CLTI), an advanced stage of peripheral artery disease (PAD), includes a subset of ‘no-option’ patients for whom conventional surgical and endovascular techniques are not possible, often necessitating amputation. Here, we present primary findings from the prospective, single arm, multicenter PROMISE II study, designed to assess the feasibility, safety, and effectiveness of transcatheter arterialization of deep veins (TADV) with the LimFlow System (Inari Medical, CA) to treat no-option CLTI patients.Methods: At twenty centers across the United States, no-option CLTI patients with Rutherford class 5 or 6 (R5 or R6) were enrolled. All patients were deemed ineligible for endovascular or surgical interventions by an independent physician review committee. Key exclusion criteria were systemic infection, rapidly deteriorating wounds, or advanced heart failure. Study conduct included an independent clinical events committee to adjudicate clinical events and a core laboratory to assess all wound images. Technical success was defined as the successful creation of an arteriovenous fistula in the target limb location with immediate morphological success as visualized via angiogram. The primary safety endpoint was above-ankle amputation-free survival at 6 months. Other endpoints at 1 year included freedom from major amputation, pain (0-10 score), wound healing, changes to SVS WIfI wound classification, and Rutherford classification.Results:Between 2018 and 2022, 105 patients underwent TADV with the LimFlow System. Technical success was 99%. At 6 months, the amputation-free survival was 66.1%. At 1 year, the freedom from major amputation was 68.8%. Pain scores improved in 76.1% of patients versus baseline and 80.8% of patients had a pain score ≤4 at 1 year. Wounds were completely healed or healing in 92% of patients at 1 year. Similarly, SVS WIfI wound classification improved in 86% of patients, and in 63.2% of patients the Rutherford score was reclassified as ≤R4 and in 55% of patients reclassified as R0. Discussion: The PROMISE II study demonstrates that TADV with the study device is a feasible, safe, and effective approach for treating no-option CLTI patients. The results demonstrate a high rate of freedom from major amputation and improved pain and wound healing at 1 year. Study follow-up is ongoing.References: